Quotient Sciences has been recognized as a multi-category winner of Clinical Leader/Life Science Leader’s 2024 CRO Leadership Awards.

For the 2024 CRO Leadership Awards, Clinical Leader/Life Science Leader and ISR Reports determined award recipients from a pool of 42 contract research organizations that were assessed on more than 20 different performance metrics in ISR’s annual CRO Quality Benchmarking survey. Winners are judged by customers as either exceeding expectations or as top performers across different categories. To ensure accurate representation, customers can only evaluate CROs they have worked with in the past 18 months.

CROs can win in up to three groups of outsourcing respondents including Big Pharma, Small Pharma, and Overall (combined Big and Small Pharma). This year, Quotient Sciences is the recipient of CRO Leadership Award recognition in Quality and Reliability (Small Pharma).

Quotient Sciences was recognized as a winner of the 2023 CDMO Leadership Awards and in the CRO Leadership Awards in 2020, 2021, and 2022. 

See all winners presented by Outsourced Pharma and Life Science Leader

The last twelve months have certainly continued to be challenging for anyone working in the global pharmaceutical and biotech industry.

Venture funding into biotech shrunk from a peak of $53.9 billion in 2021 to $24 billion in 2023 (1), the number of biotech IPOs plummeted (2), and the collapse of Silicon Valley Bank that many biotechs relied on sent shock waves through the industry, while also being marked as the second largest bank failure in U.S. history. (3) Even the largest pharmaceutical companies have been affected, with Pfizer announcing $4 billion of cost cuts following plummeting demand for its COVID-19 products. (4) With this backdrop of financial insecurity and rising inflation, all drug development companies have had to rationalize their investments and bring even greater focus on how best to spend their funds to select and advance their molecules through development as quickly as possible.

One major takeaway from 2023 was evident: with the best science, it’s possible to weather the storm and make truly ground-breaking advancements. 

After a down year in 2022, the FDA approved 55 novel therapeutics in 2023, just under the largest-ever record of 59 approvals set in 2018. (5) Among them included the world’s first medicine using CRISPR gene editing technology, Vertex Pharmaceuticals’ Casgevy, for the treatment of sickle cell anemia – a step change for the treatment of this disease. (6) Furthermore, positive data was published on GLP1 analogs’ protective effects on the heart, signaling the start of a revolution in the treatment of obesity with huge potential benefits to millions of patients globally.

At Quotient Sciences, we’ve always maintained that the quality of our science is the key to our – and our customers’ – success.

As a reflection of this, this year we have presented over 25 posters and 5 podium presentations at scientific conferences around the world, 4 papers in peer-reviewed journals, and numerous interviews in relevant industry publications. My colleagues presented on topics including 14C drug substance synthesis at the 26th Workshop of the IIS; modified release dosage form development at the Controlled Release Society; and clinical evaluation of a gastro-retentive formulation at AAPS. Data from numerous first-in-human studies was presented at conferences such as ESMO, the European Cystic Fibrosis Conference, and the International Parkinson’s Disease Conference to name a few. Additionally, our team hosted 14 seminars and 8 webinars to demonstrate our expertise through success stories and partnerships with companies including Ensysce Biosciences and Charles River. I am incredibly pleased to see my colleagues sharing their work with the wider scientific community. I’d like to say a huge thank you to them and to our collaborators for taking the time to do so.

What really strikes me is not the number but the variety of subject matter that our team showcased over the past year. The diverse subject matters of these publications reflect our unique Translational Pharmaceutics® platform that integrates conventionally siloed specialisms required to develop medicines. It was a tremendous recognition and reflection of our relentless focus on customer service, quality, and world-class science to be honored as part of the 2023 British Made Awards, the 2023 Pharma Innovation Awards, and the 2023 CDMO Leadership Awards. We support our customers with a breadth of expertise that we believe is unrivaled in the pharma services sector, and our focus on saving both time and cost in the development of medicines is something particularly prescient in the current climate.

Looking back at the year, I’m inspired by the resilience and tenacity with which we achieved these milestones amidst unprecedented challenges. 

From drug substance design and custom synthesis, drug product development and manufacturing, through to clinical testing, I am incredibly proud of the science we deliver, and I’m truly excited to see what we will achieve together with our customers and our partners in the coming year.

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Sources:

(1) 48% of biotechs relying on Big Pharma for funding: ICON survey

(2) VC funding trends in biotechnology

(3) The Silicon Valley Bank Collapse Explained

(4) Pfizer shares sink after it resets 2024 COVID expectations

(5) 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds

(6) FDA approves world's first CRISPR-based medicine for sickle cell

• Van Nieuwenhove succeeds Mark Egerton, who retires after 18 years in the role
• Wayne Hewett also joins Quotient Board of Directors as Non-Executive Chairman

NOTTINGHAM, UK; October 16, 2023: Quotient Sciences (“Quotient” or the “Company”), a leading global pharmaceutical drug development and manufacturing accelerator, is pleased to announce the appointment of Thierry Van Nieuwenhove as its new Chief Executive Officer (CEO), effective 16th October 2023.

Thierry succeeds Mark Egerton who, after 18 years of successfully leading Quotient as CEO, is retiring from executive life. As part of the leadership transition, the Company also announces that Wayne Hewett has been appointed as Non-Executive Chairman.

Thierry Van Nieuwenhove joins Quotient with an extensive track record in the pharma/CDMO services industry spanning over 23 years, and with experience in both small molecules and biologics.

Thierry joins from ABL Inc. where he was the Chief Executive Officer for the last two years. Prior to this, he held various senior leadership roles in the CDMO industry, including as the President of the Synthesis business unit at Novasep, Global Head of Business Development at Lonza, and CEO of Minakem, the CDMO and API manufacturing division of Minafin Group.

Wayne Hewett is an industry veteran who brings more than three decades of board and leadership experience to the Company. He currently serves as Chairman of Cambrex, a leading global CDMO that provides drug substance, drug product, and analytical services across the entire drug lifecycle. He also serves on the Board of Directors of The Home Depot, Inc, Wells Fargo, UPS and Lytx, and is a dedicated Senior Adviser to Permira.

Over the last few years and since its backing from the Permira funds, Quotient has seen significant growth and expansion. In 2021, the Company acquired UK-based CDMO Arcinova, expanding Quotient’s service portfolio and enabling the integration of drug substance, drug product and clinical testing capabilities all under one organization to further accelerate drug development timelines for customers.

The Company has also recently completed major investments and expansions at its Nottingham, UK and Reading, UK facilities to drive its flagship Translational Pharmaceutics offering, which continues to see strong demand and growth, including in the US.

Thierry Van Nieuwenhove said: "I am honoured to join Quotient as its new CEO and lead a team dedicated to improving the lives of patients worldwide. I have admired the company’s strong development in recent years, building a global footprint and bringing its innovative Translational Pharmaceutics delivery platform to customers across the world. I’m grateful for the opportunity and looking forward to driving the business through its next phase of growth, and continuing the team’s desire to accelerate the development of new medicines.”

Mark Egerton added: “I have been very fortunate to be part of the Quotient team for the last 18 years. The work that we do to accelerate the development of new medicines is hugely impactful to patients and the customers that we serve. I would like to thank the entire team for their hard work, diligence and collaboration over the last nearly two decades, and I am confident that the business will continue to flourish under Thierry’s leadership in the years to come.

On behalf of the board, Henry Minello, Partner, and Dimi Tzivelis, Principal at Permira, said: “Mark has served Quotient with distinction throughout his tenure. We are grateful for his leadership and wish him well in his retirement. Looking ahead, we are really delighted to welcome Thierry into the role of CEO and look forward to partnering with him, Wayne and the broader team to continue to grow this exciting business through its next phase.”

Recent advancements in drug discovery, peptide engineering and drug delivery have converged to address many of the challenges associated with oral peptide delivery. 

Technologies such as phage display can be used to create vast libraries of peptides that can be screened for properties of interest such as permeability and protease resistance, and numerous technologies – from permeation enhancers through to ingestible devices have been shown to be effective in promoting systemic absorption. 

Drugs entering clinical trials typically start with a Phase 1, first-in-human (FIH) program that includes a single ascending dose (SAD) study - starting with a sub-therapeutic dose and gradually increasing to predicted therapeutic levels before evaluating multiple ascending doses (MAD). As oral peptides usually have to be formulated with a drug delivery technology, multiple prototypes have to be developed with the knowledge that most of them will not be taken forward into later clinical development. Furthermore, given the many unknowns in oral peptide biopharmaceutics and poor correlation between preclinical models and humans, it is difficult to predict what the optimum formulation for performance in humans will be. With this considered, a drug product strategy for oral peptide programs needs to be designed that enables the program objectives to be met whilst minimizing investment required and wasted API and drug product.  

How a formulation design space works 

Using the Quotient Sciences Translational Pharmaceutics® platform, we offer an innovative solution that helps mitigate these development risks—especially when applied to molecules with known challenges such as low bioavailability.

Integrating drug product development and manufacturing services with clinical testing, we enable a just-in-time manufacturing strategy for drug products that are then dosed in the clinic as they are needed. The efficient CMC packages created as part of this platform are supported by a supply chain that Quotient Sciences controls from start to finish.  

With Translational Pharmaceutics®, formulations are optimized based on emerging clinical data, and using a formulation design space allows even greater flexibility. A formulation design space is a trusted concept that we have applied as part of RapidFACT® programs, an application of the Translational Pharmaceutics® platform, for almost two decades.  

To create a formulation design space, formulation variables are identified that are anticipated to be critical-to-performance (e.g. dose and the levels of a functional excipient). Demonstration batches are manufactured at the extremes of the design space, and batch analysis and stability data are obtained for submission to the regulatory agency to gain approval to dose any formulation within that design space. In the example shown in the figure just four demonstration batches enable the clinical evaluation of many more formulation prototypes – without any regulatory amendments or notifications, as long as the compositions remain within the pre-defined design space.

To continue reading how we have applied the Translational Pharmaceutics® platform in the development of oral peptides, with case studies from pharma/biotech customers, download our latest whitepaper.

Learn more about how a formulation design space works and watch our latest video.